You may recall my essay back in April I called “The Future Of RxTrace”. Here is an update. I am still an independent consultant, and I have decided to continue writing RxTrace, no matter what else I end up doing—whether I stay as a consultant, or get a job somewhere. It has to allow me to continue to publish RxTrace.
But I have also decided that I can no longer Continue reading The Future of RxTrace Has Arrived
The pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan. Not all are fully operational yet, but they are official. This list may be about to grow by two. Continue reading The Next Markets To Impose Pharma Serialization and Tracing?
As I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“). What does this mean for drug manufacturers, wholesale distributors and repackagers? Continue reading Pay No Attention To The Enforcement Delay Unless You Are A Dispenser
Early this morning the FDA published a revised version of its “DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy“, originally published on July 6, 2015 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“). That original document established the FDA’s intention to exercise “enforcement discretion” on dispenser transactions that fall under the Drug Supply Chain Security Act (DSCSA) dispenser requirements to receive Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement.
The revision published today pushes Continue reading FDA Extends Dispenser Delay in DSCSA Enforcement
On October 23, 2015, a very brief resolution was published in the Official Diary of the Union (Diário Oficial da União) (Brazil’s equivalent to the U.S. Federal Register) which formally suspends the 3-lot track and trace pilot that drug registration-holders were formerly required to complete by December 10 of this year (see “Brazil Suspends Pharma Serialization And Tracing Requirements”). Apparently, that makes it official. The new resolution is numbered RDC-45 and it is dated October 22, 2015. Of course, this new resolution is only available officially in Portuguese, but here is an unofficial translation of its core contents in English: Continue reading The Official Suspension of the Three-Lot Pilot in Brazil
Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.: The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar. They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people attend it: lots of people from drug manufacturers, wholesale distributors and some dispensers. With this ideal spectrum of attendees, it is very easy to get your questions answered, in the hallway between sessions if not in the sessions themselves.
Of course, every year the folks from the FDA who are directly responsible for writing regulations related to the Drug Supply Chain Security Act (DSCSA) provide Continue reading Aggregation –> Chargeback Accuracy –> ROI
One of the problems with trying to respond overnight to big announcements made by regulators is that it’s easy to leave something significant out. And in the ensuing days you find out what you should have included in those original essays. That’s what happened with my two essays from last week: “Brazil Suspends Pharma Serialization And Tracing Requirements” and “FDA Posts Wholesale Distributor and 3PL License Database“.
So let me add a few more thoughts and observations regarding Continue reading More Thoughts On FDA and ANVISA
Yesterday the U.S. FDA posted the first issue of the wholesale distributor and third-party logistics provider (3PL) database as mandated by the Drug Supply Chain Security Act (DSCSA). Through this webpage, you can either download the entire database (in .XLS form), or enter a specific query and then download that result set if desired. I couldn’t get the result set download to work, so there are obviously some bugs that need to get worked out, but this is still an important step in the implementation of the DSCSA.
With this posting, anyone who buys drugs Continue reading FDA Posts Wholesale Distributor and 3PL License Database